Overmolded textile cushion

ABSTRACT

A cushion for a respiratory mask is provided. The cushion includes a face contacting portion, a non-face contacting portion and an intermediate region. The face contacting portion is formed from an open cell foam material and includes an opening to provide, in use, a source of breathing gas to a user&#39;s airways. The non-face contacting portion is formed from an elastomeric material. The intermediate region is formed between the face contacting portion and the non-face contacting portion. Open cells of the open cell foam material in the intermediate region are filled with the elastomeric material.

FIELD OF INVENTION

The disclosure generally relates to a seal for a respiratory interface,and to an interface including the seal, comprising either a mask or amask and headgear. More particularly, certain aspects of the presentdisclosure relate to a cushion having a textile portion and anelastomeric portion.

BACKGROUND

Respiratory interfaces are used to provide respiratory gas or gases,such as air in CPAP (or other positive pressure) therapy, to a userunder positive pressure. A respiratory interface delivers the gases tothe nose and mouth of a user. The respiratory interface provides asubstantially airtight seal against the user's face such thatpressurized gases are received by the user through the respiratoryinterface.

SUMMARY OF THE INVENTION

Preferably, the respiratory interface is constructed to be soft,comfortable and lightweight when donned by the user and having anaesthetic that fits in the bedroom. The respiratory interface may beformed from a plurality of materials such that certain portions of therespiratory interface provide sufficient rigidity to inhibit collapsingdue to over-tightening of the respiratory interface during fitting.Other portions may provide a soft touch and appearance that has anaesthetic that fits in the bedroom.

The systems, methods and devices described herein have innovativeaspects, no single one of which is indispensable or solely responsiblefor their desirable attributes. Without limiting the scope of theclaims, some of the advantageous features will now be summarized.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises anopen cell foam material, the face contacting portion including anopening to provide, in use, a source of breathing gas to a user'sairways; a non-face contacting portion comprising an elastomericmaterial; and an intermediate region formed between the face contactingportion and the non-face contacting portion. The elastomeric material ofthe non-face contacting portion is received in open cells of the opencell foam material in the intermediate region.

According to a further aspect, the intermediate region extends at leastpartially around a periphery of the cushion.

According to a further aspect, the intermediate region extends around aperiphery of the cushion.

According to a further aspect, the intermediate region extends entirelyaround a periphery of the cushion.

According to a further aspect, the face contacting portion comprises amouth region and a nasal region.

According to a further aspect, the nasal region is comprised of opencell foam material.

According to a further aspect, the nasal region is comprised of atextile material.

According to a further aspect, the mouth region comprises the samematerial as the non-face contacting portion.

According to a further aspect, the intermediate region extends from theperiphery to the opening along the face contacting portion.

According to a further aspect, the face contacting portion comprises alaminate material.

According to a further aspect, the open cell foam material forms part ofa foam and fabric laminate material.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises a facecontacting portion comprising a locating region for locating a user'sface relative to the mask and a sealing region for providing a sealagainst a user's face; and a non-face contacting portion. The sealingregion surrounds the locating region, and the locating region comprisesa textile material.

According to a further aspect, the sealing region comprises anelastomeric material.

According to a further aspect, the non-face contacting portion and thesealing region comprise the same material.

According to a further aspect, the non-face contacting materialcomprises a silicone material.

According to a further aspect, the sealing region comprises a transitionregion that extends between the sealing region and the locating region.

According to a further aspect, the transition region comprises acomposite material.

According to a further aspect, the transition region comprises thetextile material that is impregnated with the elastomeric material ofthe sealing region.

According to a further aspect, in use, the transition region and sealingregion are configured to form a seal against a user's face.

According to a further aspect, the locating region comprises acontinuous surface that is breathable such that, in use, a supply ofbreathing gas can be provided to a user's airways through the locatingregion.

According to a further aspect, the locating region comprises a firstopening configured, in use, to supply a breathing gas to at least apatient's nose.

According to a further aspect, the first opening is a nasal openingconfigured to deliver a supply of breathing gas to a patient's nose.

According to a further aspect, the first opening is an oro-nasal openingconfigured to deliver a supply of breathing gas to a patient's mouth andnose.

According to a further aspect, the locating region further comprises anoral opening located, in use, below the nasal opening.

According to a further aspect, the textile material of the locatingregion comprises more than one layer.

According to a further aspect, the transition region has a greaterthickness than the locating region.

According to a further aspect, the transition region protrudes in athickness direction towards an interior of the cushion.

According to a further aspect, the transition region protrudes from aninner surface of the face contacting portions, and wherein an outersurface of the face contacting portion is a smooth continuous surface.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises a facecontacting portion including a locating region for locating a user'sface relative to the mask and a sealing region for providing a sealagainst a user's face; and a non-face contacting portion comprising anelastomeric material. The locating region is formed from a textilematerial and the textile material is configured to have a predeterminedthree-dimensional contoured shape. The sealing region is positionedaround the locating region such that the sealing region surrounds thelocating region and at least partially defines the predeterminedthree-dimensional contoured shape of the textile material.

According to a further aspect, the textile material is supported undertension by the sealing region to form the predeterminedthree-dimensional contoured shape of the textile material.

According to a further aspect, the textile material is stretchable in asingle axis.

According to a further aspect, the textile material is stretchable inmultiple axes.

According to a further aspect, the textile material is stretchable intwo axes.

According to a further aspect, the sealing region comprises a compositematerial.

According to a further aspect, the composite material comprises an outerperimeter of the stretchable textile material of the locating regionthat is over-molded with the same elastomeric material as the non-facecontacting portion, such that the textile is impregnated with theelastomeric material.

According to a further aspect, the cushion further comprises astabilizing layer, wherein the stabilizing layer comprises a layer ofelastomeric material that supports at least a portion of the locatingregion.

According to a further aspect, the stabilizing layer is located in anupper half of the face contacting portion and is configured, in use, toapply a force to a patient's nose to stabilize the cushion on thepatient's face.

According to a further aspect, the stabilizing layer extends across anasal bridge portion of the face contacting portion.

According to a further aspect, the stabilizing layer is separated fromthe textile layer.

According to a further aspect, the stabilizing layer is positioned in anasal bridge portion.

According to a further aspect, the stabilizing layer has an outer edgethat is attached to an inner perimeter of the sealing region, and aninner edge that is free.

According to a further aspect, the stabilizing layer comprises a pair ofstabilizing layers, each positioned on respective sides of the user'snose, in use.

According to a further aspect, the sealing region comprises a compositematerial and extends into the non-face contacting portion.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises a facecontacting portion; and a non-face contacting portion. At least part ofthe face contacting portion comprises a permeable material and thenon-face contacting portion comprises an elastomeric material. Thepermeable material part of the face contacting portion is joined to thenon-face contacting portion by permeation of elastomeric material intoat least part of the permeable material.

According to a further aspect, at least part of the face contactingportion comprises an elastomeric material and the permeable materialpart of the face contacting portion is joined to the non-face contactingportion by permeation of the elastomeric material of the face contactingportion into the permeable material.

According to a further aspect, an elastomeric material part of the facecontacting portion is unitary with the non-face contacting portion.

According to a further aspect, the face contacting portion comprises alocating region and a sealing region, the sealing region surrounding thelocating region, and wherein the locating region incorporates thepermeable material part of the face contacting portion.

According to a further aspect, the face contacting portion comprises alocating region and a sealing region, the sealing region surrounding thelocating region, and wherein the sealing region incorporates theelastomeric material part of the face contacting portion.

According to a further aspect, an entirety of the face contactingportion comprises a permeable material and the face contacting portionis joined to the non-face contacting portion by permeation ofelastomeric material of the non-face contacting portion into thepermeable material of the face contacting portion.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises anelastomeric sealing structure having a face contacting portion and anon-face contacting portion; and a textile layer. The textile layer ispermanently secured to an outer surface of the non-face contactingportion of the elastomeric sealing structure.

According to a further aspect, the face contacting portion comprises anelastomeric material.

According to a further aspect, the textile layer comprises a non-stretchtextile.

According to a further aspect, the textile layer further comprises asplit configured to allow the textile layer to conform to the outersurface of the non-face contacting portion of the cushion.

According to a further aspect, the face contacting portion furthercomprises a locating region for locating a user's face relative to themask and a sealing region for providing a seal against a user's face.

According to a further aspect, the locating region comprises acontinuous surface that is breathable such that, in use, a supply ofbreathing gas can be provided to a user's airways through the locatingregion.

According to a further aspect, the textile layer extends from a locatingregion of the face contacting portion to a periphery of the non-facecontacting portion that is a spaced distance from an opening defining aninlet to a breathing chamber of the cushion.

According to a further aspect, the textile layer extends from a locatingregion of the face contacting portion to an exposed periphery thatextends outwardly past an inlet of the non-face contacting portion ofthe cushion.

According to a further aspect, the locating region comprises athree-dimensional knitted textile material.

According to a further aspect, the three-dimensional knitted textilematerial of the locating region comprises more than one layer.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises aflexible sealing structure having at least one wall configured to sealagainst the face of a user; and a textile layer. The textile layer isencased within the at least one wall of the flexible sealing structure.

According to a further aspect, the textile layer is visible from theoutside of the cushion through an elastomeric material that comprisesthe flexible sealing structure.

According to a further aspect, the flexible sealing structure furthercomprises a second wall such that the at least one wall and the secondwall define a breathing chamber.

According to a further aspect, the textile layer extends continuouslyfrom the at least one wall to the second wall, and wherein the textilelayer is encased within the second wall of the flexible sealingstructure.

According to a further aspect, the at least one wall further comprises alocating region for locating a user's face relative to the mask and asealing region for providing a seal against a user's face.

According to a further aspect, the locating region comprises acontinuous surface that is breathable such that, in use, a supply ofbreathing gas can be provided to at least one of a user's airwaysthrough the locating region.

According to a further aspect, the locating region comprises athree-dimensional knitted textile material.

According to a further aspect, the three-dimensional knitted textilematerial of the locating region comprises more than one layer.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises aflexible sealing structure having a face contacting portion configuredto seal against a user's face and a non-face contacting portion, thesealing structure comprising an elastomeric layer, a first textilelayer, and a second textile layer. The first textile layer forms atleast part of the face contacting portion, the second textile layerforms at least part of the non-face contacting portion, and theelastomeric layer forms at least an internal portion of the facecontacting portion and the non-face contacting portion.

According to a further aspect, the first textile layer and the secondtextile layer are formed of a stretchable textile material.

According to a further aspect, the stretchable textile materialcomprises a laminate of one or more textile sheet layers.

According to a further aspect, at least one of the first textile layerand the second textile layer is formed of a three-dimensional knittedtextile material.

According to a further aspect, the face contacting portion comprises anoro-nasal opening configured to receive a nose and a mouth of a user.

According to a further aspect, the face contacting portion comprises abreathable locating region.

According to a further aspect, the first textile layer is formed of afirst stretchable textile material and the second textile layer isformed of a second stretchable textile material that is distinct fromthe first stretchable textile material.

According to a further aspect, the elastomeric layer joins the firsttextile layer and the second textile layer at a seam.

According to a further aspect, the cushion further comprises a bondingmaterial interposed between an inner side of the first textile layer andan inner side of the second textile layer, wherein the bonding materialjoins the face contacting portion and the non-face contacting portion todefine a breathing chamber of the cushion.

According to a further aspect, the face contacting portion and thenon-face contacting portion define a flush outer surface of the non-facecontacting portion of the cushion.

According to a further aspect, the bonding material is an elastomericmaterial.

In accordance with at least one of the embodiments disclosed herein, acushion for a respiratory mask is provided. The cushion comprises aflexible sealing structure having a first portion configured to bedisposed toward a user's face and a second portion configured to bedisposed away from the user's face; and a textile cover configured to beselectively positioned in a covering state in which the textile covercovers at least part of the first portion or an uncovering state inwhich the textile cover does not cover the first portion. The textilecover is permanently secured to the cushion.

According to a further aspect, the first portion defines a facecontacting portion and the second portion defines a non-face contactingportion of the cushion.

According to a further aspect, the textile cover further comprises afirst end secured to the cushion and a free end opposite the first end.

According to a further aspect, the first end of the textile cover ispermanently secured to an outer surface of the second portion of thecushion.

According to a further aspect, the first end of the textile cover isremovably secured to an outer surface of the second portion of thecushion.

According to a further aspect, the first portion and the second portionof the cushion define a breathing chamber.

According to a further aspect, the textile cover is secured to at leasta portion of the breathing chamber of the cushion.

According to a further aspect, the textile cover further comprises aheight that is less than a height and a width of the cushion.

According to a further aspect, the first portion of the cushion furthercomprises a sealing region configured to engage the user's face, and thetextile cover further comprises a length sufficient to allow the freeend to at least partially cover the sealing region when in the coveringstate.

According to a further aspect, the cushion further comprises anoro-nasal opening on the first portion of the cushion, wherein the freeend of the textile cover is configured to secure against the oro-nasalopening when in the covering state.

According to a further aspect, the textile cover is formed of astretchable textile material.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting of its scope, thedisclosure will be described with additional specificity and detailthrough the use of the accompanying drawings.

FIG. 1 is a view of a respiratory system comprising a flow generator, ahumidifier and a user interface.

FIG. 2A is a perspective view of a user interface, comprising a mask anda headgear, which is suitable for use with the respiratory system ofFIG. 1.

FIG. 2B is a side view of the user interface of FIG. 1.

FIG. 3A is a perspective view of an exemplary cushion for use with therespiratory system of FIG. 1.

FIG. 3B is a front view of the cushion of FIG. 3A.

FIG. 3C is a rear view of the cushion of FIG. 3A.

FIG. 3D is a side view of the cushion of FIG. 3A.

FIG. 3E is a top view of the cushion of FIG. 3A.

FIG. 3F is a bottom view of the cushion of FIG. 3A.

FIG. 4A is a perspective view of an exemplary thermoforming tool duringa step in a forming process of the cushion of FIGS. 3A to 3F.

FIG. 4B is a perspective view of the exemplary thermoforming tool andworkpiece following a step in the forming process of the cushion ofFIGS. 3A to 3F.

FIG. 4C is a perspective view of an exemplary overmolding tool and aportion of the cushion created from the workpiece following a step inthe forming process of the cushion of FIGS. 3A to 3F.

FIG. 4D is a perspective view of the exemplary overmolding tool and theportion of the cushion during a step in the forming process of thecushion of FIGS. 3A to 3F.

FIG. 4E is a perspective view of the exemplary overmolding tool during astep in the forming process of the cushion of FIGS. 3A to 3F.

FIG. 4F is a perspective view of the exemplary overmolding toolfollowing a step in the forming process of the cushion of FIGS. 3A to3F.

FIG. 5 is a perspective view of an alternative exemplary cushion havinga portion of a face contacting portion formed from silicone.

FIG. 6A is a perspective view of an alternative exemplary cushion havinga face contacting portion having a textile layer fully impregnated withsilicone.

FIG. 6B is a front view of the cushion of FIG. 6A.

FIG. 6C is a rear view of the cushion of FIG. 6A.

FIG. 6D is a side view of the cushion of FIG. 6A.

FIG. 6E is a top view of the cushion of FIG. 6A.

FIG. 6F is a bottom view of the cushion of FIG. 6A.

FIG. 7A is a perspective view of another alternative exemplary cushionhaving a face contacting portion with a sealing region formed fromsilicone and a locating region formed from a textile layer.

FIG. 7B is a front view of the cushion of FIG. 7A.

FIG. 7C is a rear view of the cushion of FIG. 7A.

FIG. 7D is a side view of the cushion of FIG. 7A.

FIG. 7E is a top view of the cushion of FIG. 7A.

FIG. 7F is a bottom view of the cushion of FIG. 7A.

FIG. 8 is a perspective view of another alternative exemplary cushionhaving a face contacting portion with a sub-nasal sling.

FIG. 9A is a perspective view of another alternative exemplary cushionhaving a face contacting portion with a raised bead on an internalsurface.

FIG. 9B is a side cross-sectional view of the cushion of FIG. 9A.

FIG. 9C is a side cross-sectional cutaway view of the cushion of FIG.9A.

FIG. 10A is a perspective view of another alternative exemplary cushionhaving a face contacting portion comprising a breathable locating regionformed from a continuous textile surface.

FIG. 10B is a front view of the cushion of FIG. 10A.

FIG. 10C is a rear view of the cushion of FIG. 10A.

FIG. 10D is a side view of the cushion of FIG. 10A.

FIG. 10E is a top view of the cushion of FIG. 10A.

FIG. 10F is a bottom view of the cushion of FIG. 10A.

FIG. 11A is a rear view of the cushion of FIGS. 10A to 10F illustratingthe cushion prior to a user's nose penetrating the breathable locatingregion.

FIG. 11B is a rear view of the cushion of FIGS. 10A to 10F illustratingdeformation of the cushion upon a user's nose penetrating a centerportion of the breathable locating region.

FIG. 11C is a rear view of the cushion of FIGS. 10A to 10F illustratingdeformation of the cushion upon a user's nose penetrating an upperportion of the breathable locating region.

FIG. 12A is a perspective view of another alternative exemplary cushionhaving a breathable locating region formed from a continuous textilesurface and a frame clip attached to a frame connection opening of thecushion.

FIG. 12B is a front view of the cushion of FIG. 12A.

FIG. 12C is a view of the cushion of FIG. 12A showing the bottom and thefront of the cushion.

FIG. 13A is a front view of an alternative exemplary cushion having anon-stretch textile located about a non-face contacting portion of thecushion.

FIG. 13B is a rear perspective view of the cushion of FIG. 13A showing aface contacting portion and an oro-nasal opening of the cushion.

FIG. 13C is a perspective view of the exemplary overmolding tool duringa step in the forming process of the cushion of FIGS. 13A and 13B.

FIG. 14A is a rear perspective view of an alternative exemplary cushionhaving a face contacting portion with a breathable locating regionconstructed of a three-dimensional knitted textile material.

FIG. 14B is a front perspective view of the cushion of FIG. 14A showinga non-face contacting portion of the cushion.

FIG. 15A is a rear perspective view of another alternative exemplarycushion having a face contacting portion with a breathable locatingregion constructed of a three-dimensional knitted textile material.

FIG. 15B is a front perspective view of the cushion of FIG. 15A showinga non-face contacting portion of the cushion in which thethree-dimensional knitted textile material extends to an opening on thenon-face contacting portion of the cushion.

FIG. 15C is a cross-sectional view of an overmolding tool during a stepin the forming process of the cushion of FIGS. 15A, 15B, and 15D.

FIG. 15D a front perspective view of part of the non-face contactingportion of the cushion of FIGS. 15A and 15B.

FIG. 16A is a cross-sectional view of a forming tool during a step inthe forming process of the cushion of FIGS. 16B and 16C.

FIG. 16B is a cross-sectional view of a part of the cushion of FIG. 16C.

FIG. 16C is a rear perspective view of an alternative exemplary cushionhaving a textile face contacting portion and a textile non-facecontacting portion.

FIG. 17A is a cross-sectional view of a forming tool during a step inthe forming process of the cushion of FIGS. 17B and 17C.

FIG. 17B is a cross-sectional view of a part of the cushion of FIG. 17C.

FIG. 17C is a rear perspective view of another alternative exemplarycushion having a textile face contacting portion and a textile non-facecontacting portion FIG. 18A is a side view of an alternative exemplarycushion having a face contacting portion, a non-face contacting portion,and a textile cover in an uncovered state.

FIG. 18B is a cross-sectional view of the cushion of FIG. 18A with thetextile cover in an uncovered state.

FIG. 18C is a rear view of the cushion of FIG. 18A with the textilecover in a covered state.

FIG. 18D is a cross-sectional view of the cushion of FIG. 18A with thetextile cover in a covered state.

DETAILED DESCRIPTION

Embodiments of systems, components and methods of assembly andmanufacture will now be described with reference to the accompanyingfigures, wherein like numerals refer to like or similar elementsthroughout. Although several embodiments, examples and illustrations aredisclosed below, it will be understood by those of ordinary skill in theart that the inventions described herein extends beyond the specificallydisclosed embodiments, examples and illustrations, and can include otheruses of the inventions and obvious modifications and equivalentsthereof. The example embodiments and/or individual features of differentembodiments may be combined, other embodiments may be utilized orstructural changes may be made, without departing from the scope of theclaimed subject matter. The terminology used in the descriptionpresented herein is not intended to be interpreted in any limited orrestrictive manner simply because it is being used in conjunction with adetailed description of certain specific embodiments of the inventions.In addition, embodiments of the inventions can comprise several novelfeatures and no single feature is solely responsible for its desirableattributes or is essential to practicing the inventions hereindescribed.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “above” and “below” refer to directions in thedrawings to which reference is made. As used herein the terms ‘front’,‘rear’, ‘upper’ and ‘lower’ shall refer to the location of a part orportion of a respiratory mask in relation to a user. Wherein, ‘front’refers to a location that is distal to the user (when the mask is inuse) and ‘rear’ refers to a location that is proximal to the user bycomparison. The terms ‘upper’ and ‘lower’ refer to the location of apart or component of a mask relative to the rest of the mask when themask is in use and the user is sitting in an upright position. Moreover,terms such as “first,” “second,” “third,” and so on may be used todescribe separate components. Such terminology may include the wordsspecifically mentioned above, derivatives thereof, and words of similarimport.

FIG. 1 is a schematic diagram of a positive pressure respiratory therapysystem in the form of a continuous positive airway pressure (CPAP)system 10 for providing a heated and humidified air stream to a user Uthrough an interface 110 worn by the user, and which is connected toCPAP system 10 by a conduit or tube 12. A humidification chamber 14 hasa heat conductive base in contact with a heater plate 16 of a humidifier17 to humidify the air stream. The conduit 12 is connected to an outlet13 of the humidification chamber 14 to convey humidified air to the userinterface 110. The humidifier 17 comprises a controller 18, such as amicroprocessor-based controller that executes computer software commandsstored in an associated memory, for example but without limitation. Thecontroller 18 receives input commands from multiple sources, including auser input interface 19 such as a dial or touch screen, which enablesthe setting of a predetermined value of humidity, temperature, or othercharacteristic of the humidified air supplied to the user U. Thecontroller 18 also may receive input from one or more other sources,such as for example temperature and/or flow velocity sensors 20 and 21,which are connected through a connector 22 to communicate with thecontroller 18, and/or a heater plate temperature sensor 23. In responseto the selected humidity or temperature value, the controller 19determines when and/or to what level the heater plate 16 should beenergized to suitably heat the water contained in the humidificationchamber 14.

As the volume of water in the chamber is heated, water vapor begins tofill the volume of the chamber above a surface of the water. The watervapor passes out of the outlet 13 of the humidification chamber with aflow of air that is provided from a supply 25, such as a blower 27, andwhich enters the humidification chamber 30 through an inlet 26. Theblower 27 can be a variable speed fan, or can include a variablepressure regulator. The blower 27 draws air through an inlet 28. Theblower can be controlled by a controller 29 or by the controller 18, forexample. The controller 18 or 29 may control blower speed, regulatedpressure, or the like according to any suitable criteria. For example,the controller 29 may respond to inputs from controller 18 and a userset value (e.g., a preset value) of pressure and/or fan speed, which canbe set with a user interface 30 (e.g., a dial).

The seal and interfaces of the disclosure can be used in such a CPAPsystem as described whether humidified or not, or alternatively in otherforms of respiratory systems, such as for example VPAP (VariablePositive Airway Pressure) systems, BiPAP (Bi level Positive AirwayPressure) systems, or with a ventilator, and are described hereingenerally with reference to CPAP therapy by way of example only.

FIGS. 2A and 2B illustrate examples of the interface assembly orinterface 110 of the system 10 of FIG. 1. The interface 110 comprises afull-face mask 112, which in some configurations includes a cushion 114and a frame assembly or frame 116. The interface 110 also includes aheadgear 118 for securing the mask 112 to the user. The full-face mask112 is configured to seal around a user's mouth and on the lowersurfaces of the user's nose. The features of the cushion embodiments, asdescribed herein, can be applied to any mask configuration including andare not limited to full-face and nasal masks or direct nasal masks.Thus, the description of features specific to full-face masks is merelyby way of example and such descriptions can be replaced with thesuitable description of another mask or interface type. For example,references to an oro-nasal opening can be replaced with a reference to anasal opening or nasal openings.

In some configurations, the interface 110 also comprises a shortflexible supply conduit or tube 120 that extends from the mask 112, suchas from a central connection at the front of the mask 112, whichconnects to the supply conduit 12 of the CPAP system 10 or otherrespiratory system. The conduit 120 is connected to the mask 112 eitherdirectly or via a suitable connector, such as a hollow elbow. In someconfigurations, the conduit 120 can swivel about one or more swivel axesrelative to the mask 112 so that the path of the conduit 120 relative tothe positioning of the mask 112 on the face of the user can adapt to thesleeping position of the user. The end of the conduit 120 opposite the122 can comprise a suitable connector for connecting the conduit 120 tothe supply conduit 12. In some configurations, the connector can be orcomprise a swivel connector that allows relative rotation between theconduit 120 and the supply conduit 12.

As described above, the mask 112 can comprise a cushion 114 and a frame116. In some configurations, the cushion 114 has a housing 124 that iscoupled to the frame 116 such that the cushion 114 and the frame 116together form an enclosure or breathing chamber having a gas flow inletfrom the CPAP system 10 and an aperture(s) 128 through the cushion 114to the user. In some configurations, the frame 116 can be stiffer thanat least a portion of the cushion 114.

Foam and Silicone Impregnated Join

FIGS. 3A to 3F illustrate an exemplary configuration of the cushion 114of the mask 112 for use with the CPAP system 10 of FIG. 1. Asillustrated, the cushion 114 comprises a user face contacting portion202 and a non-face contacting portion 204. The non-face contactingportion 204 forms a forward facing or relatively distal portion of thepartially enclosed breathing chamber 130. The face contacting portion204 forms a rearward facing or relatively proximal portion of thebreathing chamber 130 and is configured to engage with and form asubstantially airtight seal against a user's face. The face contactingportion 202 and the non-face contacting portion 204 are connected alongtheir respective edges by an intermediate region 206.

The face contacting portion 202 contacts the face of the user to providea seal that substantially encloses the nose and mouth of the user. Thatis, the face contacting portion 202 is configured to engage and form asubstantially airtight seal with a user's face. The face contactingportion 202 has an oro-nasal opening 134 which receives the nose andmouth of the user. Pressurized gases supplied by the conduit 120 entersthe breathing chamber 130 and are received by the user through theoro-nasal opening 134.

The face contacting portion 202 is formed from an open cell foammaterial. Preferably, the face contacting portion 202 is formed from anopen cell foam material 310 such that the portion of the cushion 114that contacts the user's face is soft in touch and appearance. That is,the open cell foam material 310 provides a soft touch that iscomfortable against a user's face, and an appearance that is comfortingand desirable in a bedroom environment. The open cell foam material 310also provides structure and stability to the face contacting portion 202whilst being conformable to adapt to differing facial geometries. Theopen cell foam material 310 provides a lightweight face contactingportion 202 that reduces the overall weight of the cushion 114. Alighter cushion requires lower headgear retention forces than a heaviercushion, which can improve user comfort. The open cell foam material 310may also be breathable to enable the user's skin to breathe whichimproves the comfort of the cushion 114. In some embodiments, the opencell foam material 310 may be airtight or at least have some airtightregions. In other embodiments, the open cell foam material 310 can forma leak diffuser that diffuses the flow of gas leaks to prevent orinhibit jetting which makes the leak less noticeable and disruptive to auser.

In some configurations, the face contacting portion 202 may be formedfrom a thermoformed material, which contains an open cell foam material310 such as Breath-o-prene®. The face contacting portion 202 may bethermoformed to have a three-dimensional geometry that is contoured toengage with and conform to the user's face. Preferably, the facecontacting portion 202 has a relatively thin wall structure (i.e.,thickness less than 5 mm). In some configurations, the face contactingportion 202 may have a thickness that is constant or variable along itslength, width and depth.

The open cell foam material 310 of the face contacting portion 202 mayhave an outer surface 212 that contacts a user's face. The open cellfoam material 310 is lightweight and provides a texture that is soft tothe touch and in aesthetic appearance. The open cell foam in someembodiments has a textile covering that provides the outer surface 212.In some embodiments, the open cell foam material may be in the form of alaminate containing one or more textile sheet layers. In theseembodiments, the textile may be brushed, flocked, or have a pile/nappingor texture that can engage with facial hair on a user's face. That is,the outer surface 212 may comprise a textile that is flocked. Forexample, Breath-o-prene® is a textile and foam laminate material withtextile outer layers

In some configurations, the non-face contacting portion 204 defines thehousing 124 of the cushion 114. The non-face contacting portion 204 hasa frame connection opening 132 that engages the frame 116 (see FIGS. 2Aand 2B). The frame connection opening 132 provides an inlet throughwhich a supply of pressurized air enters the breathing chamber 130. Inthe illustrated arrangement, the non-face contacting portion 204 isformed from a resilient thermoplastic elastomeric material such assilicone rubber 312 to provide a support structure and to define theairtight breathing chamber 130 which allows the supply of air to theuser's airways to be pressurized. Forming the non-face contactingportion 204 from silicone rubber 312 allows the cushion 114 to belightweight, flexible and durable. Further, the resilient siliconestructure can provide support to the face contacting portion 202 whichimproves ease of fitting the mask to the user.

The face contacting portion 202 is permanently bonded to the non-facecontacting portion 204 along the intermediate region 206. That is, theintermediate region 206 is disposed between the face contacting portion202 and the non-face contacting portion 204. In some configurations, theintermediate region 206 may be substantially defined by an outerperimeter and/or perimetric edge of at least one of the face contactingportion 202 and the non-face contacting portion 204. The face contactingportion 202, the non-face contacting portion 204 and the intermediateregion 206 together form an enclosure or breathing chamber 130 having agas flow inlet from the system 10. As will be discussed in greaterdetail below, the non-face contacting portion 204 is bonded to the facecontacting portion 202 along the intermediate region 206 by anovermolding process. As illustrated, the intermediate region 206 extendsaround a periphery of the cushion 114. In some configurations, theintermediate region 206 extends at least partially or entirely around aperiphery of the cushion 114. In some configurations, the periphery maybe defined as an outer edge or extent of the cushion 114. For example,in some configurations, the intermediate region 206 may define anoutermost circumferential edge of the cushion 114, as illustrated in thefront view of the cushion 114 in FIG. 3B. The outermost circumferentialedge of the cushion 114 is a perimetric edge between the forward-facingsurface and a rearward-facing surface of the cushion 114. In otherconfigurations, the intermediate region 206 may extend around aperiphery of the cushion 114 that is radially inward of the outermostcircumferential edge of the cushion 114. In some configurations, theintermediate region 206 may be positioned on a forward orrearward-facing surface of the cushion 114.

The intermediate region 206 comprises a seam 232 and a foam and fabriclaminate material impregnated region 234. The seam 232 provides a buttjoint between the open cell foam material 310 of the face contactingportion 202 and the silicone rubber 312 of the non-face contactingportion 204. The seam 232 is located on the forward-facing surfaces ofthe cushion 114 such that the seam 232 does not contact the user's face.The butt joint forms a smooth joint without sharp edges or steps (e.g.,a flush surface) between the outer surfaces of the cushion 114. Further,raw edges of the open cell foam material 310 of the thermoformed facecontacting portion 202 are sealed by the overmolded silicone rubber 312,which provides a tidy finish and prevents any fraying or degradation atthe edges of the face contacting portion 202. The impregnated region 234is formed by impregnating the face contacting portion 202 with siliconerubber 312 during the overmolding process such that the face contactingportion 202 and the non-face contacting portion 204 are integrallyformed. Impregnating the face contacting portion 202 with siliconerubber 312 provides a strong mechanical bond between the open cell foammaterial 310 and the silicone rubber 312, which may provide support tothe face contacting portion 202, improve durability of the cushion 114,etc.

The seam 232 extends along the edge thickness of the face contactingportion 202. In some configurations, the seam 232 extends around thelargest perimeter of the cushion (when viewed from the front or rear ofthe cushion 114) such that the seam 232 defines the perimeter of theface contacting portion 202. In some configurations, the seam 232 mayprovide a smooth and seamless transition between the face contactingportion 202 and the non-face contacting portion 204. In otherconfigurations, the face contacting portion 202 and the non-facecontacting portion 204 may comprise a ridge or protruding portion thatextends beyond the outer surfaces of the face contacting portion 202 andthe non-face contacting portion 204. The seam 232 may have a constant orvariable thickness along its length.

The intermediate region 206 is substantially formed from outer perimeterportions of both the face contacting portion 202 and the non-facecontacting portion 204. The impregnated region 234 abuts the seam 232and extends into the face contacting portion 202 from the seam 232. Thatis, an outer perimeter of the face contacting portion 202 may beimpregnated with silicone rubber 312 along the impregnated region 234.The impregnated region 234 is formed by impregnating the open cell foammaterial 310 of the face contacting portion 202 with silicone rubber 312during the overmolding process. That is, the impregnated region 234 isformed by permeating overmolded silicone into the structure of the opencell foam material 310. In some configurations, the open cells of theopen cell foam material 310 are filled with silicone rubber 312. In someconfigurations, the fibers of the textile covering that provides theouter surface 212 are saturated by silicone rubber 312.

The impregnated region 234 extends from the forward facing side of thecushion 114 into the rearward facing side of the face contacting portion202 from the seam 232. In some embodiments, an overmolding tool candetermine the shape, size and geometry of the impregnated region 234.That is, the silicone rubber 312 may be allowed to extend further intothe open cell foam material 310 in specified regions such that theimpregnated region 234 is wider, deeper and/or thicker in the specifiedregions relative to other regions. Areas where the silicone rubber 312extends a distance further into the open cell foam material 310 may bestiffer and less flexible than portions of the open cell foam material310 where the silicone rubber 312 extends a smaller or shallowerdistance into the open cell foam material 310. The shape, size and depthof the impregnated region 234 can be tailored to control or provideintentional leak paths and/or provide increased structure in specifiedregions of the face contacting portion 202.

Manufacturing Process

FIGS. 4A to 4G illustrate the steps for forming the cushion 114 from theopen cell foam material 310 and the liquid silicone rubber 312. That is,FIGS. 4A to 4G illustrate the steps for forming the face contactingportion 202 from a sheet of open cell foam material 310 and overmoldingthe non-face contacting portion 204 from liquid silicone rubber 312 ontothe face contacting portion 202 to form the cushion 114 in FIGS. 3A to3F.

As shown in FIG. 4A, an open cell foam material 310 is placed betweenfirst and second thermoforming tool portions 302, 304 of a thermoformingtool 300. The open cell foam material 310 may be in the form of alaminate containing one or more textile sheet layers. The first andsecond thermoforming tool portions 302, 304 sandwich and compress theopen cell foam material 310 such that the open cell foam material 310conforms to the 3-dimensional contours of the first and secondthermoforming tool portions 302, 304. In some configurations, a vacuummay be applied to the first and second thermoforming tool portions 302,304 to apply a force that causes the open cell foam material 310 toconform to the 3-dimensional contours of the first and secondthermoforming tool portions 302, 304 and/or to draw the open cell foammaterial 310 into the face contacting portion cavity 306 of the firstand second thermoforming tool portions 302, 304. The open cell foammaterial 310 is heated to a forming temperature such that the open cellfoam material 310 is plastically deformed according to the geometries ofthe first and second thermoforming tool portions 302, 304.

As shown in FIG. 4B, the open cell foam material 310 is cooled andremoved from the first and second thermoforming tool portions 302, 304.As shown, the open cell foam material 310 is thermoformed and retains a3-dimensional contoured shape. As shown in FIG. 4C, the open cell foammaterial 310 is cut to size and shaped to form the face contactingportion 202 of the cushion 114. That is, the open cell foam material 310is trimmed and finished to form the outer perimetric edge of the facecontacting portion 202 and a hole is formed in the open cell foammaterial 310 to provide features of the face contacting portion 202,such as the oro-nasal opening 134. In some configurations, the open cellfoam material 310 may be die cut, laser cut or the like.

As shown in FIG. 4D, the face contacting portion 202 is positionedwithin an overmolding tool 320. The face contacting portion 202 isinserted within a face contacting portion cavity 326 of a first moldingtool portion 322 of the overmolding tool 320. As shown in FIG. 4E, amolding tool core 324 is positioned over the first molding tool portion322 and enclosed by a second molding tool portion (not shown), andliquid silicone rubber 312 is injected under pressure into theovermolding tool 320 to form the non-face contacting portion 204 andalso to join the face contacting portion 202 and the non-face contactingportion 204. The molding tool core 324 functions as an inner core aroundwhich the liquid silicone rubber 312 flows for forming the enclosedbreathing chamber 130. In some configurations, the overmolding tool 320may be injected with a thermoplastic material such as thermoplasticpolyurethane (TPU), thermoplastic elastomer (TPE), thermoplasticvulcanizate (TPV), etc. After injection, the liquid silicone rubber 312is cooled and solidified. As shown in FIG. 4F, the cushion 114 isremoved from the overmolding tool 320.

During the injection of liquid silicone rubber 312 into the overmoldingtool 320, the perimeter of the face contacting portion 202 isimpregnated with liquid silicone rubber 312 which forms the intermediateregion 206. That is, the liquid silicone rubber 312 is forced to flowinto the open outer edges of the face contacting portion 202 such thatthat the face contacting portion 202 and the non-face contacting portion204 are joined along their respective edges. The seam 232 is formedbetween the face contacting portion 202 and the non-face contactingportion 204 and the impregnated region 234 is formed by injecting liquidsilicone rubber 312 into the open cell foam material 310 of the facecontacting portion 202. The liquid silicone rubber 312 is driven intothe open cell foam material 310 to form the impregnated region 234 whichextends a distance D into the face contacting portion 202 from the openouter edges of the face contacting portion 202. That is, the distance Dindicates the amount of silicone impregnation into the open cell foammaterial 310 of the face contacting portion 202.

The amount of silicone impregnation into the open cell foam material 310may vary according to the injection pressure of the liquid siliconerubber 312, the duration of injection time, thickness of the facecontacting portion 202 relative to the thickness of the non-facecontacting portion 204, etc. In some configurations, the thickness ofthe face contacting portion 202 is substantially equal to the thicknessof the non-face contacting portion 204 such that the liquid siliconerubber 312 does not flow onto the outer surface 212 of the facecontacting portion 202. In some configurations, flow into regions of theface contacting portion 202 may be restricted via narrowing or clampingof the face contacting portion 202. For example, the molding toolportions and molding tool core of the overmolding tool 320 may includeregions that clamp or narrow the thickness of the open cell foammaterial 310 of the face contacting portion 202 such that the liquidsilicone rubber 312 is inhibited from flowing into the open cell foammaterial 310.

Partial Foam and Textile Material

FIG. 5 illustrates an alternative configuration for a cushion 114 foruse with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.The cushion 114 is comprised of a face contacting portion 202 and anon-face contacting portion 204. The face contacting portion 202 iscomprised of a mouth region 142 and a nasal region 144. The non-facecontacting portion 204 is formed from silicone rubber 312. The facecontacting portion 202 has regions of silicone rubber 312 and/or opencell foam material 310. More specifically, the nasal region 144 of theface contacting portion 202 is formed from open cell foam material 310and the mouth region 142 is formed from silicone rubber 312. Forming thenasal region 144 from the open cell foam material 310 provides a softtexture in the user's nasal regions which are more sensitive topressure, whilst providing a face contacting portion 202 thateffectively seals around the user's mouth. In some configurations, thenasal region 144 may be formed from a textile material, a laminatematerial and/or a foam and fabric laminate material. Similar to cushion114, the impregnated region 234 is formed by injecting liquid siliconerubber 312 into the open cell foam material 310 of the face contactingportion 202 which provides a strong mechanical bond between the opencell foam material 310 and the silicone rubber 312, which may improvedurability of the cushion 114.

The cushion 114 includes an intermediate region 206 with an impregnatedregion 234 that extends about the perimeter of the open cell foammaterial 310. As shown in FIG. 5, the intermediate region 206 extendsfrom an outer periphery of the face contacting portion 202 and acrossthe face contacting portion 202 towards the oro-nasal opening 134. Insome configurations, a portion of the intermediate region 206 may definea portion of the oro-nasal opening 134.

As illustrated, the cushion 114 has a face contacting portion 202comprised of continuous portion or region of open cell foam material 310and a continuous portion or region of silicone rubber 312. In someconfigurations, the mouth region 142 and the non-face contacting portion204 are both unitarily formed from continuous silicone rubber 312. Thatis, the mouth region 142 and the non-face contacting portion 204 areformed from the same material. In other configurations, the mouth region142 and the non-face contacting portion 204 are formed from differentmaterials.

In some configurations, multiple continuous portions or regions of opencell foam material 310 and/or silicone rubber 312 may be positionedaround the face contacting portion 202. For example, the face contactingportion 202 may include a second open cell foam material 310 positionednear a chin contacting portion of the face contacting portion 202. Itshould be understood to one of ordinary skill in the art that regions ofthe open cell foam material 310 and/or silicone rubber 312 may bepositioned at various regions (i.e., circumferentially around, radiallyinward/outward, periodically, or any combination thereof, etc.) on theface contacting portion 202 to provide user comfort, breathability,sealability, flexibility, etc. That is, any portion of the open cellfoam material 310 may be impregnated with silicone rubber 312.

Fully Impregnated Textile Material

FIGS. 6A to 6F illustrate an alternative configuration for a cushion 414for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.The cushion 414 is comprised of a face contacting portion 202 and anon-face contacting portion 204. The face contacting portion 202comprises a composite material construction including a layer of textilematerial 310 that is overmolded with silicone rubber 312. In otherwords, the textile material 310 is fully impregnated by silicone rubber312 such that the inner and outer surfaces of the face contactingportion are both formed from silicone rubber 312. That is, an entiretyof the face contacting portion 202 is comprised of textile material 310that is impregnated with silicone rubber 312.

The fully impregnated textile material 310 of the face contactingportion 202 provides properties of both the textile material 310 and thesilicone rubber 312. The face contacting portion 202 has a textileappearance while providing a silicone rubber surface texture. Thetextile appearance may provide a softer aesthetic which may becomforting and desirable in a bedroom environment. The textile material310 may also have a contrasting colour relative to the silicone rubber312 which provides an aesthetically pleasing appearance. The contrastingcolour may also provide visual indication to the user regardinglocatability and fitment of the cushion 414 on the user's face. Thesilicone surface texture provides an airtight face contacting portionthat seals easily against a user's face. The fully impregnated textilematerial 310 also provides support structure and an airtight breathingchamber that allows the supply of air to the user's airways to bepressurized. In some configurations, the airtight structure provided bythe fully impregnated textile material 310 may be used in conjunctionwith porous and air-permeable regions such that airflow may be directedand/or diffused away from the user. The support structure also improveslocatability and fitment of the cushion against the user's face.Further, the impregnating silicone rubber 312 provides a resilientstructure that allows the face contacting portion 202 to conform to thefacial geometries of a variety of users.

In some configurations, the non-face contacting portion 204 may have agreater wall thickness (i.e., thicker) than the face contacting portion202. That is, the wall thickness of the silicone rubber 312 in the facecontacting portion 202 may be thinner than the wall thickness of thesilicone rubber 312 in the non-face contacting portion 204 such that theface contacting portion 202 may be more flexible than the non-facecontacting portion 204. Thicker non-face contacting portion 204 alsoprovides greater rigidity to the housing 124 and breathing chamber 130of the cushion 414. In some configurations, the non-face contactingportion 204 may have a substantially equal wall thickness as the facecontacting portion 202.

The cushion 414 is manufactured in an overmolding tool similar to thecushion 114. In some configurations, the textile material 310 of theface contacting portion 202 does not require thermoforming (as shown inFIG. 4A) and trimming (as shown in FIG. 4B) prior to being inserted inthe overmolding tool 320. More specifically, the textile material 310 isstretched over the first molding tool portion 322 of the overmoldingtool 320 prior to being overmolded and then excess is textile material310 trimmed. In some configurations, the textile material 310 may bepositioned within the first molding tool portion 322 and overmolded suchthat the grain of the textile material 310 follows the curvature of theface contacting portion 202. Orienting the direction of the grain of thetextile material 310 relative to the non-face contacting portion 204and/or the user may improve user comfort, sealability, locatability,aesthetics, etc.

Textile and Silicone Impregnated Join

FIGS. 7A to 7F illustrate an alternative configuration for a cushion 424for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.As illustrated, the cushion 424 comprises a user face contacting portion202 and a non-face contacting portion 204. The non-face contactingportion 204 is formed from a thermoplastic elastomeric material such assilicone rubber 312. In some configurations, the non-face contactingportion 204 may have a greater wall thickness (i.e., thicker) than theface contacting portion 202. In other configurations, the non-facecontacting portion 204 may have a substantially equal wall thickness asthe face contacting portion 202.

The face contacting portion 202 is comprised of a locating region 242and a sealing region 244. The sealing region 244 is formed from anelastomeric material such as silicone rubber 312 which provides a smoothand continuous surface that engages the user's face to form an airtightseal about the nose and mouth of the user. The sealing region 244 andthe non-face contacting portion 204 may be formed from the samematerial. For example, both the sealing region 244 and the non-facecontacting portion 204 may be formed from silicone rubber 312. In someconfigurations, the sealing region 244 and the non-face contactingportion 204 may be formed from different materials. The sealing region244 extends about the perimeter of the locating region 242. That is, thesealing region 244 is positioned radially outward of the locating region242 relative to the oro-nasal opening 134. In other words, the sealingregion 244 surrounds the locating region 242. The sealing region 244 isintegrally formed with the non-face contacting portion 204 and may be aportion of the non-face contacting portion 204 that is positioned on arearward or user-facing side of the cushion 424.

The locating region 242 is formed from a dual-layer textile material314. The textile layers of the locating region 242 are configured toconform to the user's facial geometry and locate (i.e., visually,tactily, etc.) the cushion on the user's face. In some embodiments, thedual-layer textile material 314 may comprise first and second layersthat have different properties. For example, the dual-layer textilematerial 314 may comprise a laminate material having at least one layerthat is air tight, so as to increase the sealing region 244 thatcontacts the user's face and improve the seal achieved. The dual-layertextile material 314 may also comprise at least one comfort layer, so asto increase the softness, cushioning, texture, breathability, etc. ofthe locating region 242. In some configurations, the locating region 242may comprise a single layer or a plurality of layers.

The dual-layer textile material 314 of the locating region 242 isintegrally formed with the sealing region 244. That is, an outerperimeter of the dual-layer textile material 314 is overmolded to thesealing region 244. A transition region 208 is disposed and extendsbetween the locating region 242 and the sealing region 244. As shown inFIGS. 7A and 7C, the transition region 208 may be a perimetric edgebetween the locating region 242 and the sealing region 244 that ispositioned on a rearward- and user-facing surface of the cushion 114. Insome configurations, the transition region 208 may be a perimetric edgebetween the forward-facing surface and a rearward-facing surface of thecushion 424.

The transition region 208 comprises a seam 232 and a textile impregnatedregion 234. The seam 232 is formed by a transition from the single-layertextile material 316 of the locating region 242 to the silicone rubber312 of the sealing region 244. The impregnated region 234 is formed byimpregnating the dual-layer textile material 314 of the locating region242 with silicone rubber 312 during the overmolding process such thatthe locating region 242 and the sealing region 244 are integrallyformed. Accordingly, the transition region 208 comprises a compositematerial of dual-layer textile material 314 and silicone rubber 312. Theseam 232 extends around a perimeter of the textile impregnated region234 and may provide a smooth and seamless transition between thelocating region 242 and the sealing region 244. The impregnated region234 extends about the outer radial perimeter of the dual-layer textilematerial 314, where the silicone rubber 312 permeates into thedual-layer textile material 314 from the seam 232. The transition region208 and sealing region 244 are configured to form a substantiallyairtight seal against a user's face.

Similar to the impregnation process previously described, theimpregnated region 234 is formed by impregnating the dual-layer textilematerial 314 with silicone rubber 312 using the overmolding tool 320.The overmolding tool 320 can determine the size and shape of theimpregnated region 234. That is, the silicone rubber 312 may be allowedto permeate specific regions of the dual-layer textile material 314 toprovide an impregnated region 234 with a shape that improves the sealwith the user's face. Similarly, the silicone rubber 312 may also berestricted or inhibited from permeating specific regions of thedual-layer textile material 314 to provide an impregnated region 234with a shape that permits airflow through the locating region 242. Insome embodiments, the silicone rubber 312 of the impregnated region 234can have a variable thickness (i.e. can be thicker in some regions thanothers).

The cushion 424 is manufactured in an overmolding tool similar to thecushion 114. In some configurations, the dual-layer textile material 314of the face contacting portion 202 does not require thermoforming (asshown in FIG. 4A) and trimming (as shown in FIG. 4B) prior to beinginserted in the overmolding tool 320. More specifically, the dual-layertextile material 314 is cut to size and positioned within the firstmolding tool portion 322 of the overmolding tool 320 prior to beingovermolded.

The dual-layer textile material 314 of the locating region 242 providesa 3-dimensional geometry that is softer to the touch than a siliconerubber surface and provides a colour detail to the seal. Accordingly,the cushion 424 is more comfortable against a user's face and has anappearance that is comforting and desirable in a bedroom environment.The dual-layer textile material 314 of the locating region 242 alsoprovides flexibility and conformance to the face contacting portion 202as a result of the pliable nature of the dual-layer textile material314. In some configuration, the dual-layer textile material 314 of thelocating region 242 may be formed such that a portion of the dual-layertextile material 314 is under tension. That is, tension may be inducedwithin the dual-layer textile material 314 during the overmoldingprocess. The tension may provide some resilience to enable the cushion424 to be positively located on the user's face.

Sub-Nasal Sling

FIG. 8 illustrates an alternative configuration for a cushion 434 foruse with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.As illustrated, the cushion 434 comprises a face contacting portion 202and a non-face contacting portion 204. The face contacting portion 202is comprised of a locating region 242 and a sealing region 244. Thelocating region 242 of the face contacting portion 202 is comprised of asingle-layer textile material 316 that is integrally formed with thesealing region 244. An outer perimeter of the single-layer textileregion 316 is overmolded to the sealing region 244. In someconfigurations, the locating region 242 may comprise a textile materialhaving multiple layers. In some configurations, the locating region 242may comprise a continuous surface that is formed from a breathablematerial such that, in use, a supply of breathing gas can be provided toa user's airways through the locating region.

The locating region 242 includes two openings including an oral opening136 and a nasal opening 138. The oral opening 136 is configured toencircle the user's mouth and the nasal opening 138 is configured toencircle the user's nares. That is, the oral opening 136 is configuredto provide a supply of breathing gases to the user's mouth and the nasalopening 138 is configured to provide a supply of breathing gases to theuser's nares. The oral and nasal openings 136, 138 form a sub-nasalsling 140 that is a strip of textile material that extends laterallyacross the face contacting portion 202. The sub-nasal sling 140 isconfigured to be located below the user's nose to help locate andprevent the cushion 434 from riding up the user's face. That is, thesub-nasal sling 140 inhibits improper fitment of the cushion 434 bypreventing the user's nose from penetrating too deeply into the cushion434. The sub-nasal sling 140 may be formed by cutting holes for the oraland nasal openings 136, 138 in the single-layer textile material 316. Insome configurations, the sub-nasal sling 140 is defined by the oral andnasal openings 136, 138.

A transition region 208 is disposed between the locating region 242 andthe sealing region 244. The transition region 208 comprises a seam 232and a textile impregnated region 234. The seam 232 is formed by atransition from the single-layer textile material 316 of the locatingregion 242 to the silicone rubber 312 of the sealing region 244. Theimpregnated region 234 is formed by impregnating the single-layertextile material 316 of the locating region 242 with silicone rubber 312during the overmolding process such that the locating region 242 and thesealing region 244 are integrally formed. Accordingly, the transitionregion 208 comprises a composite material of single-layer textilematerial 316 and silicone rubber 312. The seam 232 extends around aperimeter of the textile impregnated region 234 and may provide a smoothand seamless transition between the locating region 242 and the sealingregion 244.

Textile and Silicone Impregnated Join

FIGS. 9A to 9C illustrate an alternative configuration for a cushion 444for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.Similar to the cushion 434 of FIG. 8, the cushion 444 is comprised oflocating region 242 includes two openings including an oral opening 136and a nasal opening 138 which define a sub-nasal sling 140.

In contrast to the cushion 434 of FIG. 8, the cushion 444 has atransition region 208 comprised of a seam 232 with a raised bead 236 onan internal surface 218 of the face contacting portion 202. The raisedbead 236 is a portion of the face contacting portion 202 that extendsinwards toward the enclosed breathing chamber 130. As such, the seam 232has an increased thickness that extends from an interior surface of thetransition region towards the interior of the cushion 444. The raisedbead 236 extends around the seam 232 along the perimeter of the locatingregion 242. The raised bead 236 extends onto an internal orinterior-facing surface 248 of the dual-layer textile material 314. FIG.9B illustrates the raised bead 236 applied to a locating region 242formed from a single-layer textile region 316. FIG. 9C illustrates theraised bead 236 applied to a locating region 242 formed from adual-layer textile region 314. The raised bead 236 is configured toprovide increased bonding and structural strength to the seam 232. Theincreased thickness of the raised bead 236 is provided on the internalsurface 218 of the face contacting portion 202 so that the raised bead236 does not interrupt the ability of the face contacting portion 202 toform a seal against the user's face. That is, the outer surface of theface contacting portion 204 is a smooth, continuous surface whichprovides increased bonding and structural strength while also providinga comfortable surface against the user's face and a substantiallyairtight seal.

Silicone Impregnated Textile Sealing Region without Opening

FIGS. 10A to 10F illustrate an alternative configuration for a cushion454 for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.Similar to the cushion 114 of FIG. 8, the cushion 454 comprises a userface contacting portion 202 and a non-face contacting portion 204. Incontrast to the cushion 114, the cushion 454 lacks an oro-nasal opening.The face contacting portion 202 of cushion 454 comprises a continuousand uninterrupted sheet of stretchable textile material 318 withoutopenings to receive the user's nose and/or mouth. The face contactingportion 202 comprises a breathable locating region 238 and a sealingregion 244. The breathable locating region 238 is porous and airpermeable such that pressurized gases within the breathing chamber 130are received by the user through the stretchable textile material 318.In other words, the user is able to breathe through the breathablelocating region 238. In some configurations, the sealing region 244 isformed from a composite material such as a silicone rubber impregnatedopen cell foam or textile material. In other configurations, the sealingregion 244 is formed from silicone rubber 312. The sealing region 244extends about the perimeter of the breathable locating region 238. Thatis, the sealing region 244 is positioned radially outward of thebreathable locating region 238 relative to the oro-nasal opening 134. Inother words, the sealing region 244 surrounds the breathable locatingregion 238.

Similar to the cushion 114 of FIG. 8, the non-face contacting portion204 is bonded to an outer perimeter of the face contacting portion 202along the intermediate region 206 by an overmolding process. That is,the non-face contacting portion 204 includes an impregnated region 234where the stretchable textile material 318 is impregnated with siliconerubber 312 along an outer perimeter of the stretchable textile material318. The non-impregnated breathable locating region 238 of thestretchable textile material 318 is positioned radially inward of theimpregnated region 234. That is, an outer perimeter of the facecontacting portion 202 is impregnated with silicone rubber 312 and aninterior region of the face contacting portion 202 is not impregnatedwith silicone rubber 312. An outer perimeter of the breathable locatingregion 238 is defined an inner perimeter of the impregnated region 234.As illustrated in FIG. 10C, the inner perimeter of the impregnatedregion 234 and the outer perimeter of the breathable locating region 238are defined by a dashed line.

The stretchable textile material 318 of the breathable locating region238 has a predetermined three-dimensional contour at least partiallydetermined by the geometry of the sealing surface, when not in use. Thestretchable textile material 318 is supported under tension by thesealing region 244 in order to form the predetermined three-dimensionalcontour. That is, portions of the stretchable textile material 318 maybe under tension such that the breathable locating region 238 has acontoured shape when not in use and no forces are applied to thebreathable locating region 238. The breathable locating region 238 maybe formed from a material that is stretchable in a single axis, dualaxis or multiple axes. Providing axes of stretching may dictate how thebreathable locating region 238 stretches when donned by the user. Insome configurations, the breathable locating region 238 may be formedfrom a non-stretchable textile, foam or laminate material.

When donning the cushion 454, the user's nose is depressed against thebreathable locating region 238 which is displaced toward the breathingchamber 130. As illustrated in FIG. 11A to 11C, the lack of an oro-nasalopening in the face contacting portion 202 encourages the upper corners222 of the face contacting portion 202 to be pinched inwards towards thelateral sides of the user's nose when the user's nose is depressedagainst the breathable locating region 238. That is, as the user's noseprotrudes into the face contacting portion 202, the stretchable textilematerial 318 is made taut and displaced into the breathing chamber 130of the cushion 454. As a result of the stretchable textile material 318being pushed into the breathing chamber 130 of the cushion 454, thestretchable textile material 318 pulls the upper corners 222 towardseach other and into the breathing chamber 130. The upper corners 222 maydeform and/or collapse radially inward as a result of being pulledtowards each other. This results in the sealing region 244 of the facecontacting portion 202 pinching the lateral sides of the user's nose andthus improving the seal between the cushion 454 and the user's face.

The breathable locating region 238 is configured to receive the user'snose and mouth. That is, the stretchable textile material 318 may beconfigured to stretch and conform to the shape of the user's nose. Insome configurations, the breathable locating region 238 may have anamount of slack, sag or droop such that the breathable locating region238 is loose and substantially without tension when the cushion 454 isnot donned by the user. The slack reduces tension in the breathablelocating region 238 which may decrease pressure against the user's nose.In some configurations, the stretchable textile material 318 may beformed with bellows or pleats that are shaped and configured to expandwhen the user's nose is depressed into the breathable locating region238. In other configurations, the breathable locating region 238 may beformed from an elastic material such that the breathable locating region238 stretches when the user's nose is depressed against the breathablelocating region 238. In some embodiments, the stretchable textilematerial 318 may comprise a laminate material having at least one layerthat is air tight in some regions, so as to increase the sealing region244 that contacts the user's face and improve the sealability of theface contacting portion 202.

The cushion 414 is manufactured in an overmolding tool similar to thecushion 114. In some configurations, the stretchable textile material318 of the face contacting portion 202 does not require thermoforming(as shown in FIG. 4A) and trimming (as shown in FIG. 4B) prior to beinginserted in the overmolding tool 320. More specifically, the stretchabletextile material 318 is a flexible sheet that is stretched over thefirst molding tool portion 322 of the overmolding tool 320 prior tobeing overmolded. In some configurations, a vacuum may be applied to thefirst and second thermoforming tool portions 302, 304 to maintain thestretchable textile material 318 in a stretched stated. Stretching thestretchable textile material 318 prior to overmolding allows thebreathable locating region 238 to include an amount of slack, sag ordroop such that the breathable locating region 238 is loose andsubstantially without tension when the cushion 454 is not donned by theuser. Excess stretchable textile material 318 is trimmed at the seam232, after the cushion 454 has been overmolded with silicone rubber 312.The overmolding tool 320 may include shut-off zones that define andlimit how far into the stretchable textile material 318 the siliconerubber 312 can flow. The depths of penetration into the stretchabletextile material 318 will define the shape of the sealing region 244.

Providing slack in the breathable locating region 238 reduces tensionthat may be applied to the tip of the user's nose when inserted into thecushion 414. If there was no slack, then the textile material 318 wouldhave to stretch over the user's nose which may result in increasedlevels of tension being applied to the nose which may be uncomfortable.

Silicone Impregnated Textile Sealing Region with Silicone StabilizingLayer

FIGS. 12A to 12C illustrate an alternative configuration for a cushion464 for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.Similar to the cushion 454 of FIGS. 10A to 10F, the cushion 464comprises a porous and air-permeable breathable locating region 238through which the user receives pressurized gases from the breathingchamber 130. In contrast to the cushion 454, the cushion 464 includes astabilizing layer 246 beneath the stretchable textile material 318 ofthe face contacting portion 202. That is, a stabilizing layer 246 ispositioned between the breathing chamber 130 and the stretchable textilematerial 318 of the face contacting portion 202. The stabilizing layer246 is positioned on an upper half of the face contacting portion 202,and is configured, in use, to apply a force to a patient's nose tostabilize the cushion on the patient's face.

As illustrated, the stabilizing layer 246 has an inverted U-shape thatis configured to provide support to the stretchable textile material 318of the face contacting portion 202 around the user's nasal bridge andcheek regions. That is, the stabilizing layer 246 may have a contouredarch shape that extends between a cheek region of the cushion 464, oneach lateral side of the cushion 464 and over a nasal bridge region ofthe face contacting portion 202. The stabilizing layer 246 increases thestability of the cushion 464 on a user's face and prevents the housing124 from digging into the user's nasal bridge as a result of the facecontacting portion 202 collapsing due to over-tightening of the maskduring fitting. Accordingly, the stabilizing layer 246 improves thesealability of the face contacting portion 202.

The stabilizing layer 246 is formed from silicone rubber 312 and may beformed independently or integrally with the non-face contacting portion204. The stabilizing layer 246 is separate from and/or not attached tothe stretchable textile material 318. The stabilizing layer 246 has anouter edge that is attached to an inner perimeter of the sealing region244, and an inner edge that extends into the breathing chamber 130. Thatis, the stabilizing layer 246 may have a first end fixed to the sealingregion 244 and second end that is free. The stabilizing layer 246comprises a three-dimensional layer of silicone rubber that ispositioned underneath the stretchable textile material 318 of the facecontacting portion 202. The stabilizing layer 246 may have a thicknessthat is thicker, thinner or equal to the thickness of the non-facecontacting portion 204. In some configurations, the stabilising layer246 may replace or be in addition to the impregnated region 234 of thesealing region 244. In other configurations, a stabilising layer may beprovided in other regions of the cushion, such as but not limited to achin region or upper lip region (for a nasal interface). In someconfigurations, the stabilizing layer 246 may comprise multiple layersthat are, in use, each positioned on respective sides of the user'snose. In some configurations, the stabilizing layer 246 may, in use, bepositioned on respective sides of the user's nose but does not extendacross the user's nasal bridge portion.

FIGS. 9B, 11B and 11C illustrate a frame clip 252 attached to thehousing 124 of the cushion 444, 464. The frame clip 252 is a rigid ringformed from plastic that is permanently attached to the frame connectionopening 132 of the housing 124. The frame clip 252 provides a detachableconnection between the mask frame and the cushion. The frame clip 252can comprise an inner portion 254 and an outer portion 256, that arepermanently joined to each other by a snap-fit, friction-fit, weldedjoint or the like. The frame clip 252 provides a more reliableconnection to the frame than connecting the silicone housing directly tothe frame. That is, the increased rigidity of the frame clip 252decreases a likelihood of leakage between the cushion 444, 464 and theconduit 120 due to bending or deformation of the cushion 444, 464.

Partially Impregnable Textile Material

FIGS. 13A to 13C illustrate an exemplary configuration of a cushion 510for use with the CPAP system 10 of FIG. 1. The cushion 510 comprises aface contacting portion 202 and a non-face contacting portion 204. Thenon-face contacting portion 204 forms a forward facing or relativelydistal portion of the partially enclosed breathing chamber 130, asdescribed above. The face contacting portion 202 forms a rearward facingor relatively proximal portion of the breathing chamber 130 and isconfigured to engage with and form a substantially airtight seal againsta user's face. An intermediate region 206 interconnects the facecontacting portion 202 and the non-face contacting portion 204 alongtheir respective edges.

The face contacting portion 202 contacts the face of the user to providea seal that substantially encloses the nose and mouth of the user. Thatis, the face contacting portion 202 is configured to engage and form asubstantially airtight seal with a user's face. The face contactingportion 202 has an oro-nasal opening 134 which receives the nose andmouth of the user. Pressurized gases supplied by the conduit 120 entersthe breathing chamber 130 and are received by the user through theoro-nasal opening 134.

The face contacting portion 202 may comprise a sealing region 244. Asillustrated, both the face contacting portion 202 and the sealing region244 may be formed from an elastomeric material such as silicone rubber312 which provides a smooth and continuous surface that engages theuser's face to form an airtight seal about the nose and mouth of theuser (i.e., an airtight seal around the oro-nasal opening 134). Thenon-face contacting portion 204 may also be formed of silicone rubber312. Silicone rubber 312 may be positioned continuously around the facecontacting portion 202 or at various regions on the face contactingportion 202 to provide user comfort, sealability, flexibility, etc. Inother embodiments, the face contacting portion 202 and non-facecontacting portion 204 may be formed from or include differentmaterials, such as TPE materials.

The non-face contacting portion 204 may have a dual-layer constructionthat comprises a bottom or inner layer and a top or outer layer. Thebottom layer may be formed of the same silicone rubber 312 orelastomeric material as the face contacting portion 202. The top layermay be formed of a textile, such as a non-stretch textile 513, althoughthe top layer may be formed of a stretchable textile in someconfigurations. In other configurations, the top layer may be formed ofa textile 513 having a blend of two or more fibers. In suchconfigurations, the textile 513 may comprise a blend of between about70-90% Nylon and 10-30% polyester woven microfiber. For example, thetextile may comprise a blend having about 70% Nylon and about 30%polyester woven microfiber, or about 80% Nylon and about 20% polyesterwoven microfiber, or about 90% Nylon and about 100% polyester wovenmicrofiber, although other percentage compositions and other suitabletextile materials may be used. A suitable non-stretch textile 513 orstretch textile 513 will tolerate (i.e., not melt under) the hightemperatures of the tooling used during the curing process of liquidsilicone rubber 312. The non-stretch textile 513 may be positionedcontinuously around the non-face contacting portion 204, such that thenon-face contacting portion 204 is substantially covered by thenon-stretch textile 513. As illustrated in FIG. 13A, in someconfigurations, the non-stretch microfiber textile 513 may be positioneda spaced distance from the edge of the oro-nasal opening 134.Accordingly, a portion of the bottom layer of the non-face contactingportion 204 may be exposed between the non-stretch microfiber textile513 and the oro-nasal opening 134.

The non-stretch textile 513 comprises a textile formed of high-densityfibers, such as a non-stretch microfiber textile 513. Microfibertextiles such as the non-stretch microfiber textile 513 generally have afiber diameter that is less than 1 denier (i.e., less than about 10micrometer). During manufacturing of the cushion 510, the non-stretchtextile 513 is placed in a cavity of the overmolding tool 320 and liquidsilicone rubber 312 is injected into the overmolding tool 320 to jointhe non-stretch textile 513 with a portion of the injected siliconerubber 312 and form the non-face contacting portion 204 of the cushion510. The liquid silicone rubber 312 is partially driven into the fiberstructure on the user-facing side or inside of the non-stretch textile513. In contrast to the fully impregnated textile material of FIGS. 6Ato 6F, the high-density fiber structure of the non-stretch textile 513is at least partially impregnable to the flow of the liquid siliconerubber 312. Instead, during attachment of the non-stretch textile 513 tothe bottom layer of the non-face contacting portion 204, silicone rubber312 can penetrate only a portion of the thickness of the user-facingside of the non-stretch textile 513. Accordingly, the non-stretchtextile 513 is secured to the bottom layer of the non-face contactingportion 204 but forms a textile forward facing surface 511 that is notsaturated by the silicone rubber 312 on the exposed side of thenon-stretch textile 513. In some configurations, materials other thannon-stretch microfiber textile 513 may be used to form the textileforward facing surface 511, such as the such as the Breath-o-prene®material described above. In further configurations, Breath-o-prene®material forms all or part of the non-face contacting portion 204.

As described above, the non-face contacting portion 204 of the cushion510 comprises the textile forward facing surface 511 that retains thetexture, appearance, and other characteristics of the non-stretchtextile 513. The non-face contacting portion 204 is often the mostvisible or apparent aspect of the cushion 511 when it is donned by theuser. Advantageously, including the textile forward facing surface 511that retains the soft touch of the non-stretch textile 513 whileproviding a textile aesthetic that is more comforting and visuallyappealing in a bedroom environment. In some configurations, thenon-stretch textile 513 may also have a contrasting colour relative tothe silicone rubber 312 which provides an aesthetically pleasingappearance. The contrasting colour may also provide visual indication tothe user regarding locatability and fitment of the cushion 510 on theuser's face. This contrasting colour may also provide visual assemblyindicators or cues for assembling the cushion 510 with other componentsof the CPAP mask system 10. The textile forward facing surface 511 alsoprotects the underlying silicone rubber structure of the cushion 510from abrasion and wear caused by the user's hand when donning or doffingthe cushion 510.

The continuous curvature of the non-face contacting portion 204 and thenon-stretch nature of the non-stretch textile 513 increase thedifficulty of securing the non-stretch textile 513 to the non-facecontacting portion 204 while obtaining the smooth (e.g., wrinkle-free)surface finish illustrated in FIG. 13A. As illustrated in FIG. 13C, thenon-stretch textile 513 may include one or more splits 514 that allowthe substantially two-dimensional non-stretch textile 513 to conform tothe three-dimensional geometry of the overmolding tool 320 andultimately, the cushion 510. Each split 514 provides additional degreesof freedom that enable the non-stretch textile 513 to more closelyconform to the three-dimensional geometry of the cushion 510. Each ofthe one or more splits 514 may extend from an outer periphery of thenon-stretch textile 513 to an inner periphery of the non-stretch textile513. Accordingly, the split 514 may extend from the outer periphery ofthe non-stretch textile 513 to the outer perimeter of the oro-nasalopening 134. In some configurations, the split 514 may not extend theentirety of the distance between the outer and inner periphery of thenon-stretch textile 513. In further configurations, the non-stretchtextile 513 may include a split 514 that is positioned on the bottom ofthe cushion 510 (e.g., near the chin region of the user) to provide acleaner aesthetic to the portions of the cushion 510 that are visible tothe user in use.

Textile and Silicone Impregnated Join

FIGS. 14A and 14B illustrate a configuration for a cushion 520 for usewith the CPAP system 10 of FIG. 1. Similar to the cushion 454 of FIGS.10A to 10F, the cushion 520 comprises a user face contacting portion 202and a non-face contacting portion 204. The face contacting portion 202of the cushion 520 does not include an oro-nasal opening 134 but insteadcomprises a continuous and uninterrupted three-dimensional knittedtextile material 521 to receive the user's nose and/or mouth. The facecontacting portion 202 comprises a breathable locating region 238 and asealing region 244. The breathable locating region 238 is porous and airpermeable such that pressurized gases within the breathing chamber 130are received by the user through the stretchable textile material 521.The breathable locating region 238 is centrally located on the facecontact portion 202 to engage with and/or cover the nose and/or mouth ofthe user. In some configurations, the sealing region 244 is formed froma composite material such as a silicone rubber 312 that is impregnatedwithin the three-dimensional knitted textile material 521 to provide acomfortable surface against the user's face and a substantially airtightseal. In other configurations, the sealing region 244 is formed ofsilicone rubber 312 alone. The sealing region 244 extends about aportion or an entirety of the perimeter of the breathable locatingregion 238. That is, the sealing region 244 is positioned radiallyoutward of the breathable locating region 238 relative to the centroidof the cushion 520. In other words, the sealing region 244 partially orcompletely surrounds the breathable locating region 238.

Similar to the cushion 454 of FIGS. 10A to 10F, the non-face contactingportion 204 is formed along an outer perimeter of the face contactingportion 202 along the intermediate region 206 by an overmolding process.That is, the cushion 520 includes an impregnated region 234 where thethree-dimensional knitted textile material 521 is impregnated withsilicone rubber 312 within a portion or an entirety of the non-facecontacting portion 204 and along an outer perimeter of the intermediateregion 206 and/or the face contacting portion 202. Accordingly, thethree-dimensional knitted material 521 and the impregnated region 234extend only partly onto (i.e., does not completely cover) the non-facecontacting portion 204. The non-impregnated breathable locating region238 of the three-dimensional knitted textile material 521 is positionedradially inward of the impregnated region 234. That is, at least part ofan outer perimeter of the face contacting portion 202 is impregnatedwith silicone rubber 312 and at least part of an interior region of theface contacting portion 202 is not impregnated with silicone rubber 312.In some configurations, the outer perimeter of the breathable locatingregion 238 defines the inner perimeter of the impregnated region 234.

In contrast to the cushion 454 of FIGS. 10A to 10F, the face contactingportion 202 of the cushion 520 comprises a three-dimensional knittedtextile material 521 rather than a substantially two-dimensional sheetof stretchable textile material 318. A two-dimensional sheet ofstretchable textile material 318 may be limited to having apredetermined three-dimensional contour that is determined by thegeometry of the sealing region 244 when not in use. In someconfigurations, the three-dimensional knitted textile material 521comprises such a three-dimensional contour that substantially matchesthe seal geometry. Advantageously, in other configurations, thethree-dimensional knit of the three-dimensional knitted textile material521 allows the three-dimensional knitted textile material 521 tocomprise a shape, contour, or form that is independent of the geometryof the sealing region 244. Accordingly, in some configurations, thethree-dimensional knitted textile material 521 may comprise a sock, adome, an enclosed tube, or various concave three-dimensional geometries.In further configurations, the three-dimensional knitted textilematerial 521 may be customized to accommodate the specific facialfeatures of a particular user to enhance the comfort and sealability ofthe cushion 520.

When donning the cushion 520, the user's nose is depressed against thebreathable locating region 238 which is displaced toward the breathingchamber 130. The breathable locating region 238 is configured to receivethe user's nose and mouth. That is, the three-dimensional knittedtextile material 521 may be configured to stretch and conform to theshape of the user's nose. In some configurations, the grain direction ofthe three-dimensional knitted textile material 521 is tailored to createboth high-stretch and low-stretch regions throughout thethree-dimensional knitted textile material 521 of the face contactingportion 202. In further configurations, a high-stretch region may bepositioned near the center of the breathable locating region 238 toprovide increased adaptability for users having differently sized noses.In such configurations, the centrally located high-stretch regionimproves user comfort by reducing the pressure of the breathablelocating region 238 on the user's nose. Advantageously, the superioradaptability (e.g., textile shape independent of the sealing geometry,high- and low-stretch regions) offered by the three-dimensional knittedtextile material 521 allows the three-dimensional knitted textilematerial 521 to readily conform from the face contacting portion 202,around the outer perimeter of the cushion 520, and onto part of thenon-face contacting portion 204. Accordingly, the three-dimensionalknitted textile material 521 helps to minimize wrinkles (i.e., caused byexcess material) in the textile that would otherwise occur on the outerperimeter or part of the non-face contacting portion 204 as a result ofthe overmolding process.

FIGS. 15A to 15D illustrate an alternative configuration for a cushion520 for use with the CPAP system 10 of FIG. 1. Description of certainsimilarities between the two configurations may be omitted herein forthe sake of brevity and convenience, but such omission is not limiting.Similar to the cushion 520 of FIGS. 14A and 14B, the cushion 520comprises a user face contacting portion 202 and a non-face contactingportion 204 interconnected by an intermediate region 206. The facecontacting portion 202 comprises a three-dimensional knitted textilematerial 521, a breathable locating region 238, a sealing region 244,and an outer perimeter, as described above. The non-face contactingportion 204 comprises an impregnated region 234.

In contrast to the cushion 520 of FIGS. 14A and 14B, in the presentconfiguration the three-dimensional knitted material 521 extends fromthe face contacting portion 202 to the non-face contacting portion 204and completely covers the non-face contacting portion 204 of the cushion520, as illustrated in FIG. 15B. Correspondingly, in such aconfiguration, the impregnated region 234, in which thethree-dimensional knitted textile material 521 is impregnated withsilicone rubber 312, completely covers the non-face contacting portion204. As shown in FIGS. 15B and 15D, the three-dimensional knittedtextile material 521 extends from the face contacting portion 202 to thenon-face contacting portion 204 to define the breathing chamber 130. Thethree-dimensional knitted textile material 521 of the non-facecontacting portion 204 is overmolded with silicone rubber 312 such thatthe three-dimensional knitted textile material 521 of the non-facecontacting portion 204 is fully impregnated by, and thus encased in,silicone rubber 312. Accordingly, the outermost and innermost layers ofthe non-face contacting portion are formed of silicone rubber 312 withthe three-dimensional knitted textile material 521 embedded therein. Thesilicone rubber 312 of the present configuration is transparent,although some configurations may utilize semi-transparent or opaquesilicone rubber 312. The non-face contacting portion 204 thus retains atextile appearance while providing a durable silicone rubber surfacetexture. In such an embodiment, the silicone rubber outer surface of thenon-face contacting portion 204 provides a support structure and anairtight breathing chamber 130 that allows the supply of air to theuser's airways to be pressurized. The impregnated region 234 may have athickness that is thicker, thinner or equal to the thickness of theintermediate region 206 to allow the non-face contacting portion 204 toprovide support to the face contacting portion 202. Accordingly, in thepresent configuration, the face-contacting portion 202 retains thecomfort and adaptability of the breathable locating region 238 that isformed of the three-dimensional knitted textile material 521 while thenon-face contacting portion 204 retains a textile aesthetic and providesa silicone rubber support structure for the cushion 520.

In some configurations, the three-dimensional knitted textile material521 extends at least slightly beyond the impregnated region 234 suchthat non-face contacting portion 204 includes an unsaturated, exposedperiphery 525 of the three-dimensional knitted textile material 521around the opening of to the breathing chamber 130, as illustrated inFIGS. 15B and 15C. This exposed periphery 525 of the three-dimensionalknitted textile material 521 may be secured in place by the overmoldingtool 320 to prevent the three-dimensional knitted textile material 521from bunching up (e.g., wrinkling) during the overmolding process. Afterthe overmolding process is complete, the exposed periphery 525 may betrimmed or otherwise removed. The cushion 520 also provides a textileappearance throughout that provides a softer aesthetic which may becomforting and desirable in a bedroom environment. Further, the lack ofvisible seams or joins on the cushion 520 provides a visually refinedappearance that avoids rough edges which may be uncomfortable if broughtinto contact with the user's face.

FIG. 15C illustrates a cross-section of an alternative configuration ofthe overmolding tool 320 for forming the cushion 520 from thethree-dimensional knitted textile material 521 and the liquid siliconerubber 312. That is, FIG. 15C illustrates the overmolding tool 320 andcorresponding process for forming the face contacting portion 202 andnon-face contacting portion 204 from the three-dimensional knittedtextile material 521 and overmolding liquid silicone rubber 312 onto thesealing region 244, intermediate region 206, and non-face contactingportion 206. A sheet of the three-dimensional knitted textile material521 is placed on a core 528 and retained by (e.g., clamped by) the firstand second portions 526, 527 of the overmolding tool 320, which may bean open-shut style tool. The three-dimensional knitted textile material521 conforms to the core 528 due to its three-dimensional knit and high-and low-stretch regions. The first tool portion 526 defines the facecontacting portion 202 and a portion of the breathing chamber 130, andthe second tool portion 527 defines the non-face contacting portion 204,an opening for the breathing chamber 130, and at least part of thebreathing chamber 130. In some configurations, the second molding toolportion 527 secures the exposed periphery 525 of the three-dimensionalknitted textile material 521 in place to prevent the textile from beingbunched up during the molding process.

Once the three-dimensional knitted textile material 521 is securedwithin the overmolding tool 320, the liquid silicone rubber 312 isinjected into overmolding tool 320, such as through the core 528 andinto a space between the core 528 and the textile the three-dimensionalknitted textile material 521. As such, the liquid silicone rubber 312 isinjected into the interior surface of the three-dimensional knittedtextile material 521. During the injection of liquid silicone rubber 312into the overmolding tool 320, the sealing region 244, the intermediateportion 206, and the impregnated region 234 of the three-dimensionalknitted textile material 521 are impregnated with liquid silicone rubber312 to arrive at the cushion 520 illustrated in FIGS. 15A, 15B, and 15D.That is, liquid silicone rubber 312 may be allowed to permeate specificregions of the three-dimensional knitted textile material 521 to improvethe seal of the face contacting portion 202 with the user's face whilealso being restricted or inhibited from permeating the area defining thebreathable locating region 238. In some configurations, the locationregion 238 is clamped between the core 528 and the first tool portion526 to prevent silicone rubber 312 from flowing into thethree-dimensional knitted textile material 521. In some configurations,another suitable thermoplastic elastomer (e.g., TPE) may be injectedinto the overmolding tool in place of liquid silicone rubber 312. TPEincreases in density as it cools, and in some configurations, thisdensity increasing aspect of TPE can inhibit or prevent the elastomerfrom fully impregnating the three-dimensional knitted textile material521. As described above, partially impregnated textile material is anadvantageous construction as it retains the feel, appearance, and otheraspects of the textile that may be lost when the textile is fullysaturated with liquid silicone rubber 312.

Textile-to-Textile Join

FIGS. 16A to 16C illustrate the steps for forming a cushion 530 thatcomprises a face contacting portion 202 with a textile outer surface anda non-face contacting portion 204 with a textile outer surface. As shownin FIG. 16A, a first sheet of stretchable textile material 318 is placedbetween the first portion 535 and the core 534 of the overmolding tool533. A second sheet of stretchable textile material 318 is placedbetween the core 534 and the second portion 536 of the overmolding tool533. The core 534 defines the breathing chamber 130 of the cushion 530.In some configurations, one or both sheets of the stretchable textilematerial 318 may be in the form of a laminate containing one or moretextile sheet layers. In some configurations, the stretchable textilematerial 318 may comprise three-dimensional knitted textile material 521like the cushion 520. In other configurations, the stretchable textilematerial 318 may have a preformed three-dimensional shape. The firstportion 535 defines the face contacting portion 202 of the cushion 530while the second portion 536 defines the non-face contacting portion204. In some configurations, the face contacting portion 202 defines anoro-nasal opening 134, as shown in FIG. 16C. In other configurations,the face contacting portion 202 lacks an oro-nasal opening 134 butinstead includes a breathable locating region 238 similar to the cushion520 of FIGS. 14A and 14B FIGS. 15A to 15D.

The first and second sheets of stretchable textile material 318 arestretched (i.e., held in tension) as the first and second portions 535,536 of the overmolding tool 533 are clamped together around the core534. The clamping together of the first and second portions 535, 536 ofthe overmolding tool 533 against the core 534 clamps the first andsecond sheets of stretchable textile material 318 together at theirrespective edges to form a seam 537, as illustrated in FIG. 16B. Liquidsilicone rubber 312 or TPE is injected into a space between the core 534and the first and second sheets of stretchable textile material 318,such as through the core 534, which does not fully permeate to the outersurface of the stretchable textile material 318 but impregnates thebreathing chamber side of the stretchable textile material 318 with anelastomeric layer 538 that extends continuously between the face andnon-face contacting portions 202, 204 and joins the first and secondsheets of stretchable textile material 318 together at the seam 537. Insome configurations, TPE is injected into the overmolding tool 533 toimprove control over the manufacturing process of the cushion 520 bydecreasing the likelihood of fully impregnating the stretchable textilematerial 318. Any excess stretchable textile material 318 at the seam537 is trimmed or removed from the cushion 530 after the overmoldingprocess to obtain the clean seam illustrated in FIG. 16C.

Similar to the molding process described with reference to FIG. 4, theamount of silicone impregnation into the stretchable textile material318 may vary according to the injection pressure of the liquid siliconerubber 312, the duration of the injection, the thickness of the facecontacting portion 202 relative to the thickness of the non-facecontacting portion 204, the density of the stretchable textile material318, etc. Accordingly, the elastomeric layer 538 can extend from anyportion of non-face contacting portion 204 to the oro-nasal opening 134on the face contacting portion 202. In some configurations where thecushion 530 lacks an oro-nasal opening 134, the elastomeric layer 538can extend to a periphery of the face contacting portion 202 thatdefines the breathable locating region 238.

FIGS. 17A to 17C illustrate the steps for forming an alternativeconfiguration of a cushion 530. Description of certain similaritiesbetween the two processes may be omitted herein for the sake of brevityand convenience, but such omission is not limiting. Similar to thecushion 530 of FIGS. 16A to 16C, the cushion 530 of the presentembodiment comprises a face contacting portion 202 with a textile outersurface and a non-face contacting portion 204 with a textile outersurface that is formed in an overmolding process in which liquidsilicone rubber 312 or other suitable elastomeric material is injectedinto a tool. As described above, the flow of liquid silicone rubber 312or other elastomer is more readily controlled during the overmoldingprocess when the textile material covers a smaller portion of thecushion 530.

As shown in FIG. 17A, a first sheet of stretchable textile material 318is placed between the first and second portions of a first forming tool533A. A second sheet of stretchable textile material 318 is placedbetween the first and second portions of a second forming tool 533B. Theportions of the first forming tool 533A are pressed or clamped togetherand the liquid silicone rubber 312 or other suitable elastomericmaterial is injected to form the first sheet of stretchable textilematerial 318 into the face contacting portion 202. The portions of thesecond forming tool 533B are pressed or clamped together and the liquidsilicone rubber 312 or other suitable elastomeric material injected toform the second sheet of stretchable textile material 318 into thenon-face contacting portion 204. As illustrated in FIG. 17B, theovermolding process impregnates preferably the interior side of eachsheet of stretchable textile material 318 as desired with an elastomericlayer 538. In a further step, the face contacting portion 202 and thenon-face contacting portion 204 are aligned such that the edges of theportions 202, 204 abut one another in a flush manner, as illustrated inFIG. 17B. Bonding material 539 is then applied to the interior side ofthe face and non-face contacting portions 202, 204 to interconnect theportions 202, 204, thereby forming the cushion 530 as illustrated inFIG. 17C. The bonding material 539 may be liquid silicone rubber 312,another suitable elastomeric material or any suitable bonding agent andmay be applied by any suitable process.

In some configurations, the face contacting portion 202 and non-facecontacting portion 204 are connected to one another by an overmoldingprocess after being removed from the respective tools 533A, 533B. Duringthe overmolding process, the face contacting portion 202 and non-facecontacting portion 204 are aligned such that the edges of the portions202, 204 abut one another in a flush manner within an overmolding tooland silicone rubber 312 or other elastomer is then introduced to atleast the interior side of at least regions of the face and non-facecontacting portions 202, 204 adjacent the joining edges to interconnectthe portions 202, 204 and form the cushion 530.

The processes described above achieve a cushion 530 that retains atextile feel and appearance on an outer surface of the face contactingportion 202 and the non-face contacting portion 204, thereby providing asofter aesthetic that may be comforting and desirable in a bedroomenvironment. In addition, the smaller the textile component, the easierit is to control the flow of liquid silicone rubber 312 or otherelastomer during the overmolding process. In this respect, the processillustrated in FIGS. 16A to 16C is advantageous because it involves theovermolding of two textile components (e.g., the face and non-facecontacting portions 202, 204) instead of a single, larger textilecomponent. The process illustrated in FIGS. 17A to 17C is furtheradvantageous in this respect because it involves separately overmoldingthe face and non-face contacting portions which allows greater controlover the flow of the liquid silicone rubber 312 or other elastomer. Theprocess of FIGS. 17A to 17C also provides a smooth external jointbetween the portions 202, 204 that may be less noticeable, more visuallyappealing, and more comfortable to the user due to the lack of abrupt orrough edges at the joint. In some configurations, the cushion 530 maycomprise a face contacting portion 202 and a non-face contacting portionformed of different textile materials. Accordingly, the face contactingportion 202 may comprise a color, material, and/or surface finish thatis different from that of the non-face contacting portion 204. In otherconfigurations, stretchable or non-stretch textile materials 318 may beused to form either of the portions 202, 204. In configurationscomprising a breathable locating region 238, the face contacting portion202 may comprise the three-dimensional knitted textile material 521described above.

Textile Cover

FIGS. 18A to 18D illustrate a configuration for a cushion 540 for usewith the CPAP system 10 of FIG. 1. Description of certain similaritiesbetween the cushion 540 and cushions described previously may be omittedherein for the sake of brevity and convenience, but such omission is notlimiting. Similar to the cushion 510, the cushion 540 comprises a facecontacting portion 202 and a non-face contacting portion 204. The facecontacting portion 202 may be attached to (e.g. via overmolding aspreviously described) or formed integral with the non-face contactingportion 204. A breathing chamber 130 is defined within the interiorspace defined by the face and non-face contacting portions 202, 204. Insome configurations, the face contacting portion 202 comprises anoro-nasal opening 134 which receives the nose and/or mouth of the user,as illustrated in FIGS. 18A and 18B. Pressurized gases supplied by theconduit 120 enter the breathing chamber 130 and are received by the userthrough the oro-nasal opening 134. In other configurations, the facecontacting portion 202 comprises a sheet of textile material having abreathable locating region 238 through which pressurized gases aresupplied to the breathing chamber 130.

In contrast to the cushions described previously, the cushion 540comprises a textile cover 541. The textile cover 541 may be tubular orcylindrical knit tube comprising a fixed end 543 that is secured to thecushion 540 and a free end 542. The textile cover 541 may be permanentlysecured to the non-face contacting portion 204, as illustrated in FIGS.18A and 18B. In some configurations, the textile cover 541 may beremovably secured to the non-face contacting portion, such that thetextile cover 541 may be replaceable or interchangeable relative to theother portions of the cushion 540. In other configurations, the textilecover 541 may be disposed along the entirety or a substantial entiretyof the breathing chamber 130 of the cushion 540, as illustrated in FIG.18B. In some configurations, the textile cover 541 is disposed along atleast 90% of the inner surface area of the breathing chamber 130 and/orall but a rim portion surrounding an opening (e.g., opening 134 or theinlet opening) of the cushion 540. The fixed end 543 of the textilecover 541 may be overmolded to the interior (e.g. breathingchamber-facing) side of the cushion 540 using an overmolding processsimilar to those described above. In further configurations, the textilecover 541 may comprise a stretchable material, such as the stretchabletextile material 318 described previously.

The textile cover 541 is selectively movable by the user between theuncovered state of FIGS. 18A and 18B and the covered state of FIGS. 18Cand 18D. In the uncovered state, the free end 542 is removed from theface contacting portion 202 and moved toward or to the non-facecontacting portion 204, thereby exposing the face contacting portion202, the sealing region 244, and the non-face contacting portion 204, asshown in FIGS. 18A and 18B. Advantageously, in the uncovered state, thesealing region 244 can be easily cleaned independently from the textilecover 541. In some embodiments, the face and/or non-face contactingportions 202, 204 comprise a transparent elastomer such as siliconerubber 312 that allows the portions 202, 204 to retain the textileappearance of the fixed end 543 that covers the entirety of thebreathing chamber 130 of the cushion 540.

As illustrated in FIG. 18B, the textile cover 541 has a length L and adiameter D. The diameter D is less than the height and/or width of theface contacting portion 202. Accordingly, in the covered state, the freeend 542 of the textile cover 541 must be stretched to fit over thenon-face contacting portion 204, the sealing region 244, and the facecontacting portion 202. When stretched over the face contacting portion202, the free end 542 of the stretchable textile cover 541 attempts toreturn to its diameter D, which retains the free end 542 in the coveredstate. The description of the diameter D assumes a substantiallycylindrical shape having a circular cross-section. With othercross-sectional shapes, the free end 542 of the stretchable textilecover 541 preferably has a height and/or width that is smaller thancorresponding dimensions of the face contacting portion 202. In theuncovered state, the length L of the textile cover 541 extends outwardlyaway from the breathing chamber 130 and non-face contacting portion 204,as illustrated in FIG. 18B. The length L may be equal to the distancenecessary to allow the textile cover 541 to completely cover the sealingregion 244 and either overhang or overlap an edge or perimeter of theoro-nasal opening 134 when in the covered state, to thereby provide asofter sealing surface. Accordingly, in the covered state, the textilecover 541 extends radially inward into the oro-nasal opening 134 to forma textile lip that rests on or is secured to the oro-nasal opening 134.In some configurations of the covered state, the free end 542 of thetextile cover 541 is pulled over the sealing region 244 and secured tothe face contacting portion 202, as illustrated in FIG. 18D. In thecovered state of other configurations, the free end 542 is pulled overand secured around the oro-nasal opening 134, as illustrated in FIG.18C. In further configurations, the fixed end 543 of the textile cover541 is secured to the oro-nasal opening 134 and is stretched over andretained upon the non-face contacting portion 204 in the covered state.Regardless of the configuration, in the covered state, the cushion 540provides the sealability of the sealing region 244 with the soft touchand appearance of the textile cover 541 that has an aesthetic morefitting for a bedroom environment.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to”.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that thatprior art forms part of the common general knowledge in the field ofendeavor in any country in the world.

The invention may also be said broadly to consist in the parts, elementsand features referred to or indicated in the specification of theapplication, individually or collectively, in any or all combinations oftwo or more of said parts, elements or features.

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers areherein incorporated as if individually set forth.

It should be noted that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications may be madewithout departing from the spirit and scope of the invention and withoutdiminishing its attendant advantages. For instance, various componentsmay be repositioned as desired. It is therefore intended that suchchanges and modifications be included within the scope of the invention.Moreover, not all of the features, aspects and advantages arenecessarily required to practice the present invention. Accordingly, thescope of the present invention is intended to be defined only by theclaims that follow.

1-11. (canceled)
 12. A cushion for a respiratory mask, the cushioncomprising: a face contacting portion comprising a locating region forlocating a user's face relative to the mask and a sealing region forproviding a seal against a user's face; and a non-face contactingportion, wherein the sealing region surrounds the locating region, andwherein the locating region comprises a textile material.
 13. Thecushion according to claim 12, wherein the sealing region comprises anelastomeric material.
 14. The cushion according to claim 12, wherein thenon-face contacting portion and the sealing region comprise the samematerial.
 15. The cushion according to claim 12, wherein the non-facecontacting material comprises a silicone material.
 16. The cushionaccording to claim 13, wherein the sealing region comprises a transitionregion that extends between the sealing region and the locating region.17. The cushion according to claim 16, wherein the transition regioncomprises a composite material.
 18. The cushion according to claim 16,wherein the transition region comprises a textile material that isimpregnated with the elastomeric material of the sealing region.
 19. Thecushion according to claim 16, wherein, in use, the transition regionand sealing region are configured to form a seal against a user's face.20. The cushion according to claim 12, wherein the locating regioncomprises a continuous surface that is breathable such that, in use, asupply of breathing gas can be provided to a user's airways through thelocating region.
 21. The cushion according to claim 12, wherein thelocating region comprises a first opening configured, in use, to supplya breathing gas to at least a patient's nose.
 22. The cushion accordingto claim 20, wherein the first opening is a nasal opening configured todeliver a supply of breathing gas to a patient's nose.
 23. The cushionaccording to claim 22, wherein the locating region further comprises anoral opening located, in use, below the nasal opening.
 24. The cushionaccording to claim 20, wherein the first opening is an oro-nasal openingconfigured to deliver a supply of breathing gas to a patient's mouth andnose.
 25. The cushion according to claim 12, wherein the textilematerial of the locating region comprises more than one layer.
 26. Thecushion according to claim 17, wherein the transition region has agreater thickness than the locating region.
 27. The cushion according toclaim 26, wherein the transition region protrudes in a thicknessdirection towards an interior of the cushion.
 28. The cushion accordingto claim 26, wherein the transition region protrudes from an innersurface of the face contacting portions, and wherein an outer surface ofthe face contacting portion is a smooth continuous surface. 29-89.(canceled)